World
Moderna says FDA refuses its application for new mRNA flu vaccine
WASHINGTON (AP) — The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday.
The news is the latest sign of the FDA’s heightened scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr., particularly those using mRNA technology, which he has criticized before and after becoming the nation’s top health official.
Moderna received what’s called a “refusal-to-file” letter from the FDA that objected to how it conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu shots used today. That trial concluded the new vaccine was somewhat more effective in adults 50 and older than that standard shot.
The letter from FDA vaccine director Dr. Vinay Prasad said the agency doesn’t consider the application to contain an “adequate and well-controlled trial” because it didn’t compare the new shot to “the best-available standard of care in the United States at the time of the study.” Prasad’s letter pointed to some advice FDA officials gave Moderna in 2024, under the Biden administration, which Moderna didn’t follow.
According to Moderna, that feedback said it was acceptable to use the standard-dose flu shot the company had chosen — but that another brand specifically recommended for seniors would be preferred for anyone 65 and older in the study. Still, Moderna said, the FDA did agree to let the study proceed as originally planned.
The company said it also had shared with FDA additional data from a separate trial comparing the new vaccine against a licensed high-dose shot used for seniors.
The FDA “did not identify any safety or efficacy concerns with our product” and “does not further our shared goal of enhancing America’s leadership in developing innovative medicines,” Moderna CEO Stephane Bancel said in a statement.
It’s rare that FDA refuses to file an application, particularly for a new vaccine, which requires companies and FDA staff to engage in months or years of discussions.
Moderna has requested an urgent meeting with FDA, and noted that it has applied for the vaccine’s approval in Europe, Canada and Australia.
In the last year, FDA officials working under Kennedy have rolled back recommendations around COVID-19 shots, added extra warnings to the two leading COVID vaccines — which are made with mRNA technology — and removed critics of the administration’s approach from an FDA advisory panel.
Kennedy announced last year that his department would cancel more than $500 million in contracts and funding for the development of vaccines using mRNA.
FDA for decades has allowed vaccine makers to quickly update their annual flu shots to target the latest strains by showing that they trigger an immune response in patients. That’s a far more efficient approach than running long-term studies tracking whether patients get the flu and how they fare. In an internal memo last year, Prasad wrote that the streamlined method would no longer be permitted – leading more than a dozen former FDA commissioners to pen an editorial condemning the statements.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
World
Video: Nowhere Feels Safe As Israel Strikes Heart of Beirut
new video loaded: Nowhere Feels Safe As Israel Strikes Heart of Beirut
By Simona Foltyn, Adrian Hartrick, Michael Anthony Adams and Caroline Kim
March 26, 2026
World
US troops brace for ‘hit-and-run’ guerilla attacks as 82nd Airborne deploys to Iran, military analyst warns
US deploying 1,500 troops from 82nd Airborne
Chief national security correspondent Jennifer Griffin reports the latest on the conflict with Iran as about 1,500 additional troops and key staff are deployed to the Middle East.
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Iran could significantly increase U.S. casualties if its elite military and proxy forces shift to guerrilla-style hit-and-run attacks in the region, a leading military analyst has warned.
Michael Eisenstadt of the Washington Institute for Near East Policy spoke as the Pentagon moved elements of the Army’s 82nd Airborne Division into the Middle East amid a new escalation in the conflict, according to reports.
“Iran has large infantry units in its military that are equivalent to the brigade combat team of the 82nd Airborne,” Eisenstadt, a former U.S. Army Reserve officer, told Fox News Digital.
“The 82nd Force is too small to cause significant harm to Iran, but it is large enough to be vulnerable to Iranian strikes, and this would enable Iran to significantly increase U.S. casualties,” he said.
HEGSETH WARNS ‘MORE CASUALTIES’ EXPECTED IN OPERATION EPIC FURY AGAINST IRAN
The 82nd Airborne Division deployment to the Middle East is intended to pressure Iran into accepting U.S. ceasefire terms, military analyst Michael Eisenstadt says. (Sarah Blake Morgan/AP Photo)
Eisenstadt, who has worked as a U.S. government military analyst, claimed that, even if major conventional operations begin to wind down in the Middle East region, the danger may only evolve rather than disappear.
“We could see an end to major combat operations, with activity shifting to guerrilla-style hit-and-run attacks in the Gulf and other gray-zone activities by Iran,” he said.
“Think of the aftermath of the 1991 Gulf War with Iraq, in which we had to contain the Iraqis for a decade after a very successful war.”
US COULD TAKE IRAN’S MAIN OIL EXPORT HUB ‘AT A TIME OF OUR CHOOSING,’ JACK KEANE SAYS
Naval units from Iran and Russia simulate the rescue of a hijacked vessel during joint drills, Feb. 19, at the Port of Bandar Abbas in Hormozgan, Iran. (Iranian Army/Handout/Anadolu via Getty Images)
Fox News chief national security correspondent Jennifer Griffin reported Wednesday that the U.S. has ordered the deployment of an additional 82nd Airborne forces to the region.
The contingent is expected to include Maj. Gen. Brandon R. Tegtmeier, the division commander, elements of his headquarters staff, and infantry battalions from the division’s Immediate Response Force.
Officials also indicated that the total number of troops ultimately sent could still change.
Eisenstadt said this new deployment is intended to increase pressure on Tehran as the U.S. pushes for new ceasefire terms, set in place by President Donald Trump.
WINNING THE BATTLES, LOSING THE WAR? AMERICA MUST DEFINE THE ENDGAME IN IRAN
President Donald Trump speaks with the media before boarding Air Force One, Monday, at Palm Beach International Airport in West Palm Beach, Fla. (Mark Schiefelbein/AP Photo)
“This deployment is intended to create leverage over Iran and pressure it to accept U.S. terms for a ceasefire agreement. It would also create military options if Iran rejects those terms,” he said.
In that scenario, he said, the 82nd could potentially operate alongside Marine expeditionary units in operations to seize and hold terrain, including Kharg Island, located roughly 20 miles off Iran’s Gulf coast.
U.S. forces struck military targets there March 13, destroying more than 90 Iranian military sites while deliberately sparing key oil infrastructure, according to multiple reports.
IRAN’S REMAINING WEAPONS: HOW TEHRAN CAN STILL DISRUPT THE STRAIT OF HORMUZ
Satellite view of Kharg Island, located in the Persian Gulf off the coast of Iran. (Gallo Images/Orbital Horizon/Copernicus Sentinel Data 2024)
“The brigade combat team of the 82nd could work with the 11th and 31st MEUs, or independently, to seize and hold terrain — such as Kharg Island,” Eisenstadt said.
“This would provide leverage over Iran by denying it the ability to export oil and helping end the war on terms favorable to the U.S.”
“There are risks involved though, because Iranian units on the mainland could bombard Kharg Island and inflict casualties on U.S. troops there also,” Eisenstadt said.
JACK KEANE WARNS CEASEFIRE WITH IRAN WOULD ‘PLAY RIGHT INTO THEIR HANDS’ AS TRUMP SIGNALS DEAL PROGRESS
President Donald Trump warned on Saturday that the U.S. could strike Iranian power plants if the Strait of Hormuz is not reopened. (Aaron Schwartz/UPI/Bloomberg via Getty Images; Gallo Images/Orbital Horizon/Copernicus Sentinel Data 2025 via Getty Images)
The latest military buildup comes as the conflict that began with Operation Epic Fury on Feb. 28, has also centered on the Strait of Hormuz, with Iran restricting access.
“The 82nd deployment is intended to increase psychological pressure on Iran and support efforts to reopen the Strait of Hormuz so it can once again be used by all countries,” Eisenstadt explained.
The 82nd Airborne is one of the U.S. military’s premier rapid-response units, trained to parachute into hostile or contested territory to secure key ground and airfields.
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Portions of the division have also spent recent days at the Joint Readiness Training Center, sharpening infiltration, surveillance, combat and resupply skills, Axios reported.
“Iranian military officials have welcomed news of the dispatch of these units to the Gulf because it potentially creates options for them to impose costs on the U.S.,” Eisenstadt said.
World
Escalation in the Middle East – Not Europe’s war? MEPs in the Ring
Published on
Imagine a former five-star army general in the same room as an anti-war activist? That is what we witness on this latest edition of The Ring, Euronews’ weekly debate show.
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Riho Terras, an Estonian general and centre-right MEP, went face-to-face with far-left Turkish-born German MEP Özlem Demirel on the role of the EU in the ongoing war in the Middle East.
As the conflict enters its fourth week, EU leaders have called for “de-escalation, the protection of civilians, and restraint,” while avoiding direct involvement. But the question of whether Brussels should take a stronger stance has exposed deep divisions.
“We know from history that military means and wars never brought democracy to this region,” Demirel said, adding starkly: “Bombs fall, the stock markets rise, people die.”
Riho Terras disagreed and took a more security-focused line, defending the need for military strength in global politics. “Nobody listens to somebody who does not have military means,” he argued, stressing that diplomacy alone is insufficient without power behind it.
This episode of The Ring is anchored by Méabh Mc Mahon, produced by Luis Albertos and Amaia Echevarria, and edited by Vassilis Glynos.
Watch The Ring on Euronews TV or in the player above and send us your views by writing to thering@euronews.com
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